(1) Objectives: This study aims at investigating the effectiveness of mindfulness-integrated cognitive behavior therapy on pregnant women’s depression, anxiety, and quality of life at Kashan.
(2) Design: This is a pretest-post test experimental study. The intervention also includes a one-month follow-up course.
(3) Methods: A sample of 70 eligible pregnant women will be recruited. Women will be randomly allocated to either the experimental or the control groups. The women in the experimental group will receive mindfulness-integrated cognitive behavior therapy while the women in the control group will receive no intervention. Study instruments include the Edinburgh Postnatal Depression Scale, the Beck Anxiety Inventory, and the Quality of Life Questionnaire. These instruments will be completed before, immediately after, and one month after the intervention.
(4) Inclusion criteria: Having an age of 18–50 years and a gestational age of 2–6 months.
(5) Exclusion criteria: Obtaining a score of less than 13 on the Edinburgh Postnatal Depression Scale, obtaining a score of less than 16 on the Beck Anxiety Inventory, receiving psychotherapy or drug therapy during the six months prior to the study, and having a previous history of suicide.
(6) Intervention: The intervention of this study is a mindfulness-integrated cognitive behavior therapy which includes eight 90-minute sessions.
(7) Primary outcomes: The primary outcomes are depression, anxiety, and quality of life.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2015012920869N1
Registration date:2015-06-02, 1394/03/12
Registration timing:retrospective
Last update:
Update count:0
Registration date
2015-06-02, 1394/03/12
Registrant information
Name
Reza Yazdanimehr
Name of organization / entity
Kashan University of Medical Sciences and Health Services
Country
Iran (Islamic Republic of)
Phone
+98 31 5554 0021
Email address
yazdanimehr-re@kaums.ac.ir
Recruitment status
Recruitment complete
Funding source
Vice chancellor for research Kashan University of Medical Sciences and Health Services
Expected recruitment start date
2015-02-24, 1393/12/05
Expected recruitment end date
2015-03-01, 1393/12/10
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Controlled trial of effectiveness of Mindfulness integrated Cognitive Behavior Therapy on depression, anxiety and quality of life in pregnant women
Public title
Effectiveness of Mindfulness integrated Cognitive Behavior Therapy in pregnant women
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria
1. Being in the second to sixth months of pregnancy;
2. Having an age of 18–50 years; and
3. Having a degree in secondary education or higher.
Exclusion criteria:
1. Obtaining a score of less than 13 on the Edinburgh Postnatal Depression Scale;
2. Obtaining a score of less than 16 on the Beck Anxiety Inventory;
3. Having a known-cause depression or anxiety following problems such as loss, marital conflicts, unwanted pregnancy, and divorce;
4. Having a history of psychotic disorders;
5. Receiving psychotherapy or drug therapy during past six months;
6. Opting for withdrawing from the study;
7. Failing to participate in more than two sessions of the study intervention;
8. Having a preterm delivery;
9. Having a previous history of suicide; and
10. Having a history of addiction.
Age
From 18 years old to 50 years old
Gender
Female
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
70
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Seventy eligible pregnant women will be recruited by using the convenience sampling method and allocated to either the control or the experimental groups by drawing.
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Kashan University of Medical Sciences and Health Services
Street address
Vice chancellor for research of Kashan University of Medical Sciences and Health Services, Pezeshk Blvd, 5th of Qotbe Ravandi Blvd
City
Kashan
Postal code
Approval date
2014-12-17, 1393/09/26
Ethics committee reference number
29/5/1/4770/پ
Health conditions studied
1
Description of health condition studied
Depression
ICD-10 code
F32.0
ICD-10 code description
Two or three of the above symptoms are usually present. The patient is usually distressed by these but will probably be able to continue with most activities.
2
Description of health condition studied
Anxiety
ICD-10 code
F49.1
ICD-10 code description
Anxiety NOS
Primary outcomes
1
Description
Depression
Timepoint
Before intervention, After intervention, One month after intervention
Method of measurement
Edinburgh Postpartum Depression Scale
2
Description
Anxiety
Timepoint
Before intervention, After intervention, One month after intervention
Method of measurement
Beck Anxiety Inventory
3
Description
Quality of life
Timepoint
Before intervention, After intervention, One month after intervention
Method of measurement
Quality of life questionnaire
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group;
Mindfulness-integrated cognitive behavior therapy; A systematic therapeutic approach which integrates mindfulness with cognitive behavior therapy. The aim of this approach is to help clients internalize their attention and hence, regulate their emotions and attention and use these skills for managing their problems in their immediate environments.
Category
Behavior
2
Description
Control group;
Will receive no intervention.
Category
Other
Recruitment centers
1
Recruitment center
Name of recruitment center
Akramiyan health services center
Full name of responsible person
Zahra Aqazadeh
Street address
Akramiyan health services center, 22 Bahman St
City
Kashan
2
Recruitment center
Name of recruitment center
Ketabchi health services center
Full name of responsible person
Zahra Sabzikariyan
Street address
Ketabchi health services center, Bahonar Blvd, Moalem Sq
City
Kashan
3
Recruitment center
Name of recruitment center
Taleqani health services center
Full name of responsible person
Zohreh Rabbani
Street address
Taleqani health services center,Taleqani St
City
Kashan
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Vice chancellor for research of Kashan University of Medical Sciences and Health Services
Full name of responsible person
Dr Qolam Ali Hamidi
Street address
Vice chancellor for research of Kashan University of Medical Sciences and Health Services, Pezeshk Blvd, 5th of Qotbe Ravandi Blvd
City
Kashan
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Vice chancellor for research of Kashan University of Medical Sciences and Health Services
Proportion provided by this source
100
Public or private sector
empty
Domestic or foreign origin
empty
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
empty
Person responsible for general inquiries
Contact
Name of organization / entity
Kashan University of Medical Sciences and Health Services
Full name of responsible person
Reza Yazdanimehr
Position
M.Sc candidate in clinical psychology
Other areas of specialty/work
Street address
Department of Clinical Psychology, School of Medicine, Kashan University of Medical Sciences and Health Services, Pezeshk Blvd, 5th of Qotbe Ravandi Blvd
City
Kashan
Postal code
Phone
+98 31 5554 0021
Fax
Email
rym1368@yahoo.com; yazdanimehr-re@kaums.ac.ir
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Kashan University of Medical Sciences and Health services
Full name of responsible person
Reza yazdanimehr
Position
M.Sc candidate in clinical psychology
Other areas of specialty/work
Street address
Department of Clinical Psychology, School of Medicine, Kashan University of Medical Sciences and Health Services, Pezeshk Blvd, 5th of Qotbe Ravandi Blvd
City
Kashan
Postal code
Phone
+98 31 5554 0021
Fax
Email
rym1368@yahoo.com؛ yazdanimehr-re@kaums.ac.ir
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Kashan University of Medical Sciences and Health Services
Full name of responsible person
Reza Yazdanimehr
Position
M.Sc candidate in clinical psychology
Other areas of specialty/work
Street address
Department of Clinical Psychology, School of Medicine, Kashan University of Medical Sciences and Health Services, Pezeshk Blvd, 5th of Qotbe Ravandi Blvd
City
Kashan
Postal code
Phone
00
Fax
Email
rym1368@yahoo.com
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)